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Off-the-Radar Biotechs About to Break Out – Daily Reckoning

By raymumme

Some big scientific breakthroughs are set to take place this year.

And fortunes could be made with a few off-the-radar biotech pioneers.

What I am talking about are the handful of small biotech companies applying regenerative medicine platforms to degenerative diseases and ailments like paralysis.

These degenerative diseases have always been tough to treat, and few therapies are available. Thats not surprising, since weve lacked until recently the ability to create healthy and functioning human cells to replace ones lost in the body to injury and disease.

Now, though, a handful of breakthrough companies are aiming to correct that lack with new pluripotent stem cell technology.

Stem cells have the ability to reproduce and change into functional cells and tissues. And pluripotent stem cells are the most potent. They can turn into any cell type in the human body. Furthermore, they can divide and reproduce without end.

This makes them an ideal starting point for manufacturing cell-based therapies.

One company using this platform to help heal spinal cord injuries and paralysis is already heaving great success in FDA trials with a new cell line.

Their recent FDA Phase 1 trial data shows that patients treated with a new cell line are seeing a significant return of nerve function thanks to these grafts.

And last month, this same company announced nine-month follow-up data for patients that were given a 10 million cell dose to their injury. Even though this is only half of what researchers believe will be a full dose, at least 50% of patients have already shown signs of recovery.

This includes two levels of improvement in motor function, as well as improvements in arm, hand and finger function.

The nine-month data confirms what the company reported at three and six months, too.

Showing us that the new cell therapy has great durability. The introduced cells help heal the injury, and the result is more than temporary.

Under the accumulating evidence, the FDA has also decided to approve an expansion to this trial to include patients with spinal cord injury at the C4 location which is in the middle of the neck.

This is a very significant development.

The C4 spinal location is one of the most common locations for a spinal cord injury, and it often results in paralysis from the neck down.

And now the FDA is allowing the company to expand its treatment window from 1430 days after injury to 2142 days.

All these data bode very nicely for the future.

And not only for the developers of this specific cell therapy, but for other small biotech companies also trying to carve out market share in the pluripotent stem cell therapy space.

According to the National Spinal Cord Injury Statistical Center, there are some 17,000 new spinal cord injuries per year. This represents a large potential market for any company that masters this new technology and provides viable treatments for degenerative injuries.

Even more promising is that this new cell technology may also be used to treat cancer. And another group of tiny biotech companies are leading the way in research for this application, too.

We hope to see the data from these other FDA trials focusing on developing cancer vaccines during the second half of 2017.

If any of these new trial results comes back positive as early indications are showing, then were looking a tsunami sized wave of new opportunities in biotech. And for the handful of small companies and their investors, this should be a game changer.

As it stands currently, most of the companies making the push into regenerative medicine using new stem cell technology remain largely undiscovered.

As the FDA data become more actionable and these treatments move closer to market introduction, there will be some great plays to make.

And when that happens Ill be right here to make sure you have the best chance for the big score with this new technology.

To a bright future,

Ray Blancofor The Daily Reckoning

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Stem Cells Market Analysis By Product (Adult Stem Cells, hESC … – PR Newswire (press release)

By Sykes24Tracey

NEW YORK, July 12, 2017 /PRNewswire/ -- The global stem cell market is expected to reach USD 15.63billion by 2025, growing at a CAGR of 9.2%, according to a new report by Grand View Research, Inc.

Augmentation in research studies that aim at broadening the utility scope of associated products is anticipated to drive the market growth. These research projects have opened the possibility of implementation of several clinical applications of these cells, thereby impacting disease-modifying treatments.

Read the full report: http://www.reportlinker.com/p04998556/Stem-Cells-Market-Analysis-By-Product-Adult-Stem-Cells-hESC-Induced-Pluripotent-Stem-Cells-By-Application-Regenerative-Medicine-Drug-Discovery-By-Technology-By-Therapy-And-Segment-Forecasts.html

Scientists are engaged in discovering novel methods to create human stem cells. This is to address the increasing demand for stem cell production for potential investigation in disease management. This factor is certainly expected to accelerate the development of regenerative medicine, thus driving industrial growth.

Moreover, cellular therapies are recognized as the next major advancements in transforming healthcare. Firms are expanding their cellular therapy portfolio, understanding the future potential of this arena in the treatment of Parkinson's disease, type 1 diabetes, spinal cord injury, Alzheimer's disease, and others.

In March 2016, Scientists at Michigan State University unveiled new kind of cells "induced XEN cells" from a cellular trash pile. This discovery is expected to drive advancements in regenerative medicine. Such discoveries are anticipated to bolster research and sales in this market over the forecast period.

Further key findings from the report suggest: Adult stem cells dominated the market and is expected to maintain its dominance. This can be attributed to the several factors such as lower rejection rates, long term renewal property, and no ethical concerns associated with their usage Application wise regenerative medicine is estimated to hold the substantial share of the revenue Presence of significant number pipeline projects for regenerative medicine is expected to fuel growth in the market In addition, exploding research projects have driven the need of harvesting techniques, thereby propelling progress of acquisition technology Increased R&D activities and huge funds granted by funding bodies to advance cellular research in the U.S. have resulted into the large share of North America Extensive research carried out in Singapore and Japan is anticipated to drive progress with lucrative avenues Advanced Cell Technology Inc, Osiris Therapeutics Inc, Celgene Corporation, BIOTIME, INC., Cynata, and STEMCELL Technologies Inc., are some of the major companies operating in this market A number of companies are engaged in seeking investment from overseas organizations and also developing partnerships with the pharmaceutical organizations

Read the full report: http://www.reportlinker.com/p04998556/Stem-Cells-Market-Analysis-By-Product-Adult-Stem-Cells-hESC-Induced-Pluripotent-Stem-Cells-By-Application-Regenerative-Medicine-Drug-Discovery-By-Technology-By-Therapy-And-Segment-Forecasts.html

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Cell therapy may be key to treating Alzheimer’s & Parkinson’s – Economic Times

By NEVAGiles23

According to recent study, advancements in materials from this study could potentially help patients requiring stem cell therapies for spinal cord injuries, stroke, Parkinsons disease, Alzheimers disease, arthritic joints or any other condition requiring tissue regeneration. Earlier research revolved around the role of autoimmunity in terms of a treatment.

Its important in the context of cell therapies for people to cure these diseases or regenerate tissues that are no longer functional, shared Samuel I. Stupp, director of Northwesterns Simpson Querrey Institute for BioNanotechnology and Board of Trustees Professor of Materials Science and Engineering, Chemistry, Medicine and Biomedical Engineering.

Cells in our bodies are constantly being signalled with many types of instructions coming from proteins and other molecules present in the matrices that surround them. For example, these can be cues for cells to express specific genes so they can proliferate or differentiate into several types of cells leading to growth or regeneration of tissues. One of the marvels of this signalling machinery is the built-in capacity in living organisms to make signals stop and restart as needed, or to switch off one signal and activate a different one to orchestrate very complex processes.

Building artificial materials with this type of dynamic capacity for regenerative therapies has been virtually impossible so far. The new work published today reports the development of the first synthetic material that has the capability to trigger reversibly this type of dynamic signalling. The platform could not only lead to materials that manage stem cells for more effective regenerative therapies, but will also allow scientists to explore and discover in the laboratory new ways to control the fate of cells and their functions.

One of the findings is the possibility of using the synthetic material to signal neural stem cells to proliferate, then at a specific time selected by the operator, trigger their differentiation into neurons and then return the stem cells back to a proliferative state on demand. The paper also reports that spinal cord neural stem cells, initially grouped into structures known as neurospheres, can be driven to spread out and differentiate using a signal.

But when this signal is switched off, the cells spontaneously regroup themselves into colonies. This uncovers strong interactions among these cells that could be important in understanding developmental and regenerative cues. The potential use of the new technology to manipulate cells could help cure a patient with Parkinsons disease. The patients own skin cells could be converted to stem cells using existing techniques.

The new technology could help expand the newly converted stem cells in vitro in the lab and then drive their differentiation into dopamine-producing neurons before transplantation back to the patient. In the new technology, materials are chemically decorated with different strands of DNA, each designed to display a different signal to cells.

People would love to have cell therapies that utilize stem cells derived from their own bodies to regenerate tissue. In principle, this will eventually be possible, but one needs procedures that are effective at expanding and differentiating cells in order to do so. Our technology does that, noted Stupp. While this process is currently only done in vitro with the vision of then transplanting cells, Stupp said in the future it might be possible to perform this process in vivo.

The stem cells would be implanted in the clinic, encapsulated in the type of material described in the new work, via an injection and targeted to a particular spot. Then the soluble molecules would be given to the patient to manipulate proliferation and differentiation of transplanted cells. The study was published in journal Nature Communications.

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Asterias Biotherapeutics Receives FDA Clearance to Enroll C-4 Patients in SCiStar Study – PR Newswire (press release)

By NEVAGiles23

"The FDA's decision to allow Asterias to enroll qualified patients with C-4 level injuries is the result of the data supporting the safety of both AST-OPC1 and the procedure to inject the cells, and means that the second most common cervical spinal cord injury population can now be eligible to receive AST-OPC1," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "The overall changes to the study protocol will enhance our ability to enroll qualified patient candidates for our current SCiStar study and we also expect the changes to help enrollment rates in a future, larger clinical study."

The protocol amendment will expand patient eligibility and enable study investigators to administer AST-OPC1 to patients with injuries at one vertebral level higher than the trial's previous C-5 limitation, to the fourth cervical vertebra down, known as C-4, near the middle of the neck. A C-4 cervical level injury, the second most common level of SCI in the SCiStar study's targeted patient population, generally means that the injured person is paralyzed from the neck down and requires round-the-clock care. The lifetime direct costs of care for a patient suffering a high cervical spinal cord injury, such as a C-4 spinal cord injury, can approach $5 million. As suggested by existing research, if these patients can show two motor levels of improvement on at least one side they may regain the ability to perform daily activities such as feeding, dressing and bathing, which increases their quality of life and independence and significantly reduces the overall level of required daily assistance and associated healthcare costs for these patients.

In addition, the amendment to inclusion parameters will also expand the dosing window to 21 to 42 days after a patient's spinal cord injury occurs, providing study investigators more time to screen patients to determine if they are eligible to participate in the SCiStar study. The expansion of the dosing window is supported by recent preclinical research that indicated AST-OPC1 cells can durably engraft at a patient's injury site when administered up to two months after the date of injury.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is being administered 21 to 42 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at http://www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells originally isolated in 1998, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries in the current SCiStar study, which represents the first targeted population for registration trials. Asterias has completed enrollment in the first two cohorts of this study. Results to date have continued to support the safety of AST-OPC1, with no serious adverse events related to AST-OPC1 or its administration. Additionally, Asterias has recently reported results suggesting reduced cavitation and improved motor function in patients administered AST-OPC1 in the SCiStar trial.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at http://www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias' filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

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SOURCE Asterias Biotherapeutics, Inc.

http://www.asteriasbiotherapeutics.com

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Asterias Biotherapeutics Receives FDA Clearance to Enroll C-4 Patients in SCiStar Study - PR Newswire (press release)

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Private clinics are peddling untested stem cell treatments it’s unethical and dangerous – Yahoo News UK

By LizaAVILA

Getty Images/Spencer Platt

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

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Donna McWilliam/APRather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

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REUTERS/Juan Carlos UlateAt present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

NOW WATCH: America's B-2 stealth bomber is unlike any military aircraft in the world

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Stem Cell Therapy: You can be sexually active again – Vanguard … – Vanguard

By JoanneRUSSELL25

By David Ikudayisi

Stem Cell Therapy comes in different types. Embryonic Stem Cell Therapy involves the use of embryonic stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo at 4 days old to around 12 days old, leading to the destruction of the blastocyst which raises ethical and religious issues. Therefore, this type of Stem Cell Therapy is not the focus of this piece. The focus is Adult Stem Cells (ADSCs) and Induced Pluripotent Stem Cells (iPSCs). iPSCs are produced in the laboratories by reprogramming adult cells to express embryonic stem cells characteristics whereas ADSCs are cells obtained from an adult patient who will also be the recipient of the same stem cells.

In the United States, we must transplant the cells back to the same patient on the same day, while in some countries, the stem cells can be cultured to increase the quantity of stem cells before transplanting them back to the same patient who donated them.

Stem Cell Transplantation is a complex process that needs the care of experts in Regenerative Medicine, a new speciality of medicine . In order to ensure that science remains as the vehicle for hope and not harm, the controversies associated with the legal, social and legal issues of certain areas of stem cells research and stem cells potential clinical applications must be carefully examined. Advancing treatment and care for patients to save a life is and must be the ultimate goal.

Regenerative Medicine helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to, but Adult Stem Cells Platelet Rich Plasma (PRP), that is, blood plasma that has been enriched with platelets, and contains growth factors which may elicit the gathering of stem cells around the damaged region stimulating cellular proliferation and tissue regeneration. PRP can be used to promote healing of injured tendons, ligaments, muscles, joints and can be applied to various musculoskeletal problems. The process allows your own (autologous) stem cells to be re-introduced into/around areas of damage or chronic disease. As mentioned earlier, the extraction and transplantation of the stem cells are done on the same day in the United States. Bone marrow transplant has been the most widely used Stem Cell Therapy till date, but Adult Adipose-Derived (fat) Stem Cell Therapy is fast gaining popularity as fat harvesting is less invasive than bone marrow harvesting. You get more stem cells from fat than bone marrow, and fat stem cells are not age-dependent. Adult Stem Cell Therapy may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. The therapy, with or without PRP, revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related. Generally, Adult Stem Cell Therapy is safe as shown by many published research reports and clinical trials. However, this does not guarantee that adverse effects cant occur if the treatment is done by physicians that are not properly trained.

The therapy has helped a lot of people all over the world to regain their lives from debilitating ailments and Nigerians are not left behind. There are people in Nigeria that were either wheelchair bound and walking with occasional use of a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger. It has helped chronic kidney disease patients in Nigeria that are on hemodialysis to either reduce the frequency of hemodialysis per week or like a patient that was recommended to have kidney transplant a year ago but who is now off hemodialysis and off diabetic medications, and remains stable for the past months. Men with Erectile Dysfunction are now feeling like young men again. I cannot but mention that the type of treatment protocol and dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients, in studies, showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results. The only group of patients that will always need more than a couple of transplantation sessions are patients with neurological disorders. Latest researches and evidence-based studies showed the number of treatment sessions needed to get significant clinical results can decrease by adding Exosomes to the treatment sessions.

In a recently publication in Germany, the new concept, developed around 2010 of how stem cells works, was reinforced where it stated that most of the effects of stem cells are through the Paracrine effects, delivered by the Exosomes. Exosomes are extracellular cell-derived vesicles that are present in almost all biological fluids. When secreted by stem cells, Exosomes are those tiny communication vesicles that interact with surrounding cells, thereby creating therapeutic activity. This is called the Paracrine effect. The Paracrine soluble factors (communication vesicles) have specialized functions and play a key role in intercellular signaling and in the following properties immune modulatory, neuroprotective, anti-inflammatory, neurotrophic, angiotrophic, anti-apoptotic and anti-oxidatory. Stem cells also secrete other important proteins and cytokines that have healing properties.

There are some diseases that conventional treatments have no cure for, but Adult Stem Cell Therapy can reverse the symptoms of those diseases, repair and regenerate the damaged tissues or organs affected. In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like Rheumatoid Arthritis, Lupus, Scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like ALS and spinal cord injury.

Adult Stem Cell Therapy can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and upregulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of Adult Stem Cells.

A procedure called P-Shot for Men uses the PRP Therapy to resolve challenges relating to Erectile Dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery.

Since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant. Nevertheless, as with any procedure, there is a risk of infection which can be very minimal or non-existent if done under the right conditions. Adult Stem Cells Transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease. The cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that health is wealth.

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Embryonic stem cells to be available for medical use in Japan by next March – The Japan Times

By NEVAGiles23

KYOTO Embryonic stem cells for regenerative medicine will become available to medical institutions by the March 2018 end of fiscal 2017, Hirofumi Suemori, associate professor at Kyoto Universitys Institute for Frontier Life and Medical Sciences, has said.

Suemori also said Tuesday that ES cells for medical treatment, which have been approved by both the health and science ministries, would be created from October at the earliest.

To make ES cells, Kyoto University will work with Adachi Hospital in the city of Kyoto, which offers infertility treatment, to use fertilized eggs that would otherwise be disposed of.

The university hopes to obtain unwanted fertilized eggs from patients undergoing infertility treatment. The fertilized eggs are expected to be provided from around next February, the university said.

ES cells have the potential to become a variety of cell types much as induced pluripotent stem (iPS) cells do. Using ES cells, clinical trials are being conducted abroad on retinopathy, spinal cord injuries, Parkinsons disease, diabetes and cardiac disorders.

Many patients have qualms about discarding fertilized eggs, said Adachi Hospital Director Hiroshi Hatayama, who joined Suemori for a news conference. We can present an option to them, Hatayama said.

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Embryonic stem cells to be available for medical use in Japan by next March - The Japan Times

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Stem cell-based therapies to treat spinal cord injury: a review – Dove Medical Press

By Dr. Matthew Watson

Zhongju Shi,1,2 Hongyun Huang,3 Shiqing Feng1,2

1Department of Orthopaedics, Tianjin Medical University General Hospital, 2Institute of Neurology, Key Laboratory of Post-Neuroinjury Neuro-Repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin City, Tianjin, 3Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, Peoples Republic of China

Abstract: Spinal cord injury (SCI) is a devastating condition and major burden on society and individuals. Currently, neurorestorative strategies, including stem cell therapy products or mature/functionally differentiated cell-derived cell therapy products, can restore patients with chronic complete SCI to some degree of neurological functions. The stem cells for neurorestoration include neural stem cells, mesenchymal stem cells, embryonic stem cells, induced pluripotent stem cells, etc. A better understanding of the merits, demerits and precise function of different stem cells in the treatment of SCI may aid in the development of neurorestorative strategies. However, the efficacy, safety and ethical concerns of stem cell-based therapy continue to be challenged. Nonetheless, stem cell-based therapies hold promise of widespread applications, particularly in areas of SCI, and have the potential to be novel therapeutics, which contributes to the repair of SCI. This review mainly focused on recent advances regarding the stem cell-based therapies in the treatment of SCI and discussed future perspectives in this field.

Keywords: spinal cord injury, neural stem cells, bone marrow-derived mesenchymal stem cells, adipose-derived stem cells, embryonic stem cells, induced pluripotent stem cells

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Dog owners flock IVRI for pets’ cure | Bareilly News – Times of India – Times of India

By LizaAVILA

BAREILLY: Dog owners from across the country, including Delhi and Gujarat, are turning up with their paralytic pets at the Indian Veterinary Research Institute (IVRI) here for stem cell therapy. Scientists treat a paralyzed dog by transplanting stem cells from healthy dogs. IVRI is the second institute in the country to offer this treatment, after Madras Veterinary College, Chennai.

According to scientists, no research has been conducted to determine the number of dogs who suffer from paralysis every year in India. However, the institute receives at least four cases every week of spinal trauma which causes paralysis in dogs. IVRI recorded 143 cases of posterior paralysis in 2016. These were treated with stem cell therapy and medicines.

"If dogs are treated only with medicines, recovery is witnessed only in a few cases," said Amarpal (who goes by his first name), head and principal scientist, division of surgery, IVRI. On an average, 17% recovery rate was noted among dogs administered only medicines.

However, the best response was recorded among severely affected dogs when they were treated using stem cells, where almost all the patients responded to treatment to variable extent, said the scientist. "Though we have cases where recovery was 100%, the average recovery rate is about 50%. The experiment proved the efficacy of stem cell therapy in cases of paralysis due to spinal trauma," said Amarpal. After seven years of research, stem cell therapy was started at IVRI five years ago for clinical purposes on a nominal registration fee of Rs 30.

Due to its success, pet owners from various parts of the country have started visiting the institute.

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Canadian clinics begin offering stem-cell treatments experts call unproven, possibly unsafe – National Post

By daniellenierenberg

The arthritis in Maureen Munsies ankles was so intense until barely a year ago, she literally had to crawl on hands and knees to get upstairs.

The pain, she recalls now, took my breath away, and played havoc with the avid hikers favourite pastime.

In desperation, Munsie turned to a Toronto-area clinic that provides a treatment many experts consider still experimental, unproven and of questionable safety.

The 63-year-old says the stem cells she received at Regenervate Medical Injection Therapy 18 months ago were transformational, all but eliminating the debilitating soreness and even allowing her to hike Argentinas Patagonia mountains two months ago.

For me its been a life saver, Munsie says. Ive been able to do it all again I dont have any of that pain, at all.

Canadians drawn to the healing promise of stem cells have for years travelled outside the country to such places as Mexico, China or Arizona, taking part in a dubious form of medical tourism.

But Regenervate is one of a handful of clinics in Canada that have begun offering injections of stem cells, satisfying growing demand but raising questions about whether a medical idea with huge potential is ready for routine patient care.

Especially when those patients can pay thousands of dollars for the service.

Clinics in Ontario and Alberta are treating arthritis, joint injuries, disc problems and even skin conditions with stem cells typically taken from patients fat tissue or bone marrow.

The underlying idea is compelling: stem cells can differentiate or transform into many other types of cell, a unique quality that evidence suggests allows them to grow or regenerate tissue damaged by disease or injury.

Researchers including hundreds in Canada alone are examining stem-cell treatments for everything from ailing hearts to severed spinal cords.

With few exceptions, however, the concept is still being studied in the lab or in human trials; virtually none of the treatments have been definitively proven effective by science or approved by regulators like Health Canada.

The fact that Canadian clinics are now offering stem-cell treatments commercially is concerning on a number of levels, not least because of safety issues, says Ubaka Ogbogu, a health law professor at the University of Alberta.

Three U.S. women were blinded after receiving stem-cell injections in their eyes, while other American patients have developed bony masses or tumours at injection sites, Ogbogu said.

Stem cells have to be controlled to act exactly the way you want them to act, and thats why the research takes time, he said. It is simply wrong for these clinics to take a proof of concept and run with it.

Ogbogu says Health Canada must crack down on the burgeoning industry but says the regulator has so far been conspicuous by its inaction.

Other experts say the procedures provided here typically for joint pain are likely relatively safe, but still warn that care must be taken that the stem cells do not develop into the wrong type of tissue, or at the wrong place.

Alberta Health Services convened a workshop on the issue late last year, concluding there is an urgent need to develop a certification system for cell preparation and delivery to avoid spontaneous transformation of (stem cells) into unwanted tissue.

But one of the pioneers of the service in Canada says theres no empirical evidence that such growths can develop, and suggests the treatments only real risk as with an invasive procedure is infection.

Meanwhile, patients at Regenervate have enjoyed impressive outcomes after paying fees from $750 to $3,900, says Dr. Douglas Stoddard, the clinics medical director.

About 80 per cent report less pain, stiffness and weakness within a few months of getting their stem-cell injection, he said.

I believe medical progress is not just limited to the laboratory and randomized double-blind trials, Stoddard said. A lot of progress starts in the clinic, dealing with patients You see something works, you see something has merit, and then its usually the scientists that seem to catch up later.

The Orthopedic Sport Institute in Collingwood, Ont., the Central Alberta Pain and Rehabilitation Institute and Cleveland Clinic in Toronto all advertise similar stem-cell treatments for orthopedic problems.

Edmontons Regen Clinic says it plans to start doing so this fall.

Ottawas Innovo says it also treats a range of back conditions with injections between the vertebrae, and uses stem cells to alleviate nerve damage.

Orthopedic Sport says its doctor focuses on FDA and Health Canada approved stem-cell injection therapy for patient care.

In fact, no treatment of the sort the clinics here provide has ever been authorized.

Health Canada says the vast majority of stem-cell therapies would constitute a drug and therefore need to be authorized after a clinical trial or new drug submission.

A number of stem-cell trials are underway, but only one treatment Prochymal has been approved, said department spokesman Eric Morrissette. Designed to combat graft-versus-host disease where bone marrow transplants for treating cancer essentially attack the patients body its unlike any of the services the stem-cell providers here offer.

But as the U.S. Food and Drug Administration aggressively pursues the hundreds of clinics in America, Health Canada says only that its committed to addressing complaints it receives.

It will take action based on the risk posed to the general public, said Morrissette, who encouraged people to pass on to the department information about possible non-compliant products.

Stoddard said the injections his clinics provide are made up of minimally manipulated tissue from patients own bodies and any attempt to crack down would be regulation for the sake of regulation.

But academic experts remain skeptical about the effectiveness of the treatments.

Scientific evidence suggests the injections may help alleviate joint pain temporarily, but probably just because of anti-inflammatory secretions from the cells not regeneration, said Dr. David Hart, an orthopedic surgery professor at the University of Calgary who headed the Alberta workshop.

Theres a need for understanding whats going on here and theres a need for regulation, he said.

Most of the clinics say they use a centrifuge to concentrate the stem cells after removing them from patients fat tissue or bone marrow. But its unclear if the clinics even know how many cells they are eventually injecting into patients, says Jeff Biernaskie, a stem-cell scientist at the University of Calgary.

Munsie, on the other hand, has no doubts about the value of her own treatment, even with a $3,000 price tag.

The procedure from extraction of fat tissue in her behind to the injection of cells into her ankles took barely over an hour.

Within three months, the retired massage therapist from north of Toronto says she could walk her dogs again. Last week, she was hiking near Banff.

Im a real believer in it, and the possibility of stem cells, says Munsie. I just think Wow, if we can heal with our own body, its pretty amazing.

tblackwell@nationalpost.com

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Spinal Cord Nerve Cells Positional Decoding In Development – ReliaWire

By Dr. Matthew Watson

Cells destined to become nerve cells in developing mouse embryos use two different signals spreading from opposite sides of the spinal cord the back and belly side to measure their position accurately. Based on this map, they turn into the appropriate nerve cell type.

These are the findings from a new a study by researchers at the Francis Crick Institute, the Institute of Science and Technology and Ecole Polytechnique Fdrale de Lausanne. The results could give insight into regenerative medicine.

As embryos grow and develop they need the right cell types to end up in the right places inside forming organs. This is particularly important in the spinal cord where different nerve cell types must be accurately positioned so that circuits can assemble properly to control muscle movement.

But until now the mechanism underlying nerve cell organization in the spinal cord has remained poorly understood.

The team of biologists, physicists and engineers found that the amounts of the two signals originating from the back and belly sides of the body affect gene activity in developing nerve cells. Based on this gene activity in early development, the cells turn into the appropriate nerve cell type for that position in the spinal cord.

Weve made an important step in understanding how the diverse cell types in the spinal cord of a developing embryo are organised in a precise spatial pattern. The quantitative measurements and new experimental techniques we used, as well as the combined effort of biologists, physicists and engineers were key. This allowed us to gain new insight into the exquisite accuracy of embryonic development and revealed that cells have remarkable ability of to orchestrate precise tissue development,

says Anna Kicheva, Group Leader at IST Austria.

We have shed light on the long-standing question of how developing tissues produce the right cells in the right place in the right numbers. Its likely that similar strategies are used in other developing tissues and our findings might be relevant to these cases. In the long run this will help inform the use of stem cells in approaches such as tissue engineering and regenerative medicine. However, there is still much more to learn and we need to continue developing these interdisciplinary collaborations to further our biological understanding,

says James Briscoe, Group Leader at the Francis Crick Institute.

Image: normal developing spinal cord (left) showing precise patterns of gene activity (red, blue, green demarcating different types of cells). In a spinal cord in which one of the signals is disrupted (right) the accuracy of gene activity has been lost. Credit: Anna Kicheva

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GEN Roundup: Top Trends in Tissue Engineering – Genetic Engineering & Biotechnology News

By Dr. Matthew Watson

References

1. F.T. Moutos et al., Anatomically shaped tissue-engineered cartilage with tunable and inducible anticytokine delivery for biological joint resurfacing, Proc. Natl. Acad. Sci. U.S.A. 113 (31) E4513E4522, doi: 10.1073/pnas.1601639113.

2. B. Zhang et al., Biodegradable scaffold with built-in vasculature for organ-on-a-chip engineering and direct surgical anastomosis, Nat. Materials 15, 669678 (2016), doi:10.1038/nmat4570.

3. S. Shukla et al., Progenitor T-cell differentiation from hematopoietic stem cells using Delta-like-4 and VCAM-1, Nat. Methods 14(5), 531-538 (May 2017),doi: 10.1038/nmeth.4258. Epub Apr 10, 2017.

4. M.M. Pakulska, S. Miersch, and M.S. Shoichet, Designer protein delivery: from natural occurring to engineered affinity controlled release systems, Science 351(6279):aac4750, doi: 10.1126/science.aac4750.

5. M.M. Pakulska, C.H. Tator, and M.S. Shoichet, Local delivery of chondroitinase ABC with or without stromal cell-derived factor 1 promotes functional repair in the injured rat spinal cord, Biomaterials (accepted April 2017).

6. TissueGene, TissueGene to Highlight Invossa, the Worlds First Cell-Mediated Gene Therapy for Degenerative Osteoarthritis, at JP Morgan Healthcare Conference, Press Release,accessed June 12, 2017.

7. O.J.L. Rackham et al., A predictive computational framework for direct reprogramming between human cell types, Nat. Genetics 48, 331335 (2016), doi:10.1038/ng.3487.

8. D.B. Kolesky et al., Three-dimensional bioprinting of thick vascularized tissue, Proc. Natl. Acad. Sci. U.S.A. 113 (12), 31793184, doi: 10.1073/pnas.1521342113.

9. M.M. Laronda et al., A Bioprosthetic Ovary Created Using 3D Printed Microporous Scaffolds Restores Ovarian Function in Sterilized Mice, Nat. Commun. 8, 15261 (May 16, 2017).

10. I. Sagi et al., Derivation and differentiation of haploid human embryonic stem cells, Nature 532, 107111 (April 7, 2016), doi:10.1038/nature17408.

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Wheelchair-bound Langley man raising funds for stem cell therapy in Central America – Surrey Now-Leader

By Sykes24Tracey

Logan Van Dyk hopes stem cell operation in Central America will open doors for him ones that shut abruptly on Aug. 3, 2008.

It took seconds for the now 26-year-old Fort Langley residents life to change.

On that day nearly nine years ago, just after he graduated from R.E. Mountain Secondary, Van Dyk suffered a life-altering spinal cord injury in a mountain biking incident.

I was fooling around on a construction site with some friends and I accidentally fell off a dirt pile on my bike, recalled Van Dyk, who was born and raised in Langley. I fell 25 feet and landed on my face.

Van Dyk suffered a spinal cord injury that left him bound to a wheelchair, as a partial quadriplegic.

I got a C56 spinal cord injury, but its incomplete which means theres always a possibility for recovery, Van Dyk said.

Its that hope that has Van Dyk looking to travel to Panama for therapy.

He started doing some research on stem cells and found an institute in Panama City that offers treatments.

Van Dyk sent in an application and on March 8 received an email saying he will make an excellent candidate for stem cell therapy.

Of course there is no guarantee that I will gain anything back but at this point Im willing to try anything to improve the quality of my life, said Van Dyk, who hopes to get into broadcasting.

He has created a GoFundMe page to raise what he believes is the $45,000 necessary to pay for flights, treatments, accommodations, and a personal nurse in Panama City. Visit http://www.gofundme.com/anw8ce-stem-cell-research.

The therapy itself will cost roughly $37,400 US. As well, there are no nurses at the institute who would assist Van Dyk directly.

I receive care twice a day in order to get in and out of my wheelchair and in and out of bed, Van Dyke explained. So I need to get a bit of extra money so I can hire a nurse to come down with me. Im not sure how much that is going to cost.

A friend who works as a nurse guided Van Dyk towards the possibility of travelling to Panama.

She couldnt believe there was nothing that could be done given the circumstances of my injury, Van Dyke said, because Ive got feeling all the way down to my toes. She looked into it and she found this down in Panama City. We looked at it and found some testimonials from some people who have gone down. They say they have about a 75 per cent success rate.

Van Dyk said he always does his best to remain positive and happy in everything he does.

Even the most basic of things take all my effort to achieve, Van Dyk said on his GoFundMe page. There just had to be something out there that could make things easier.

However, time is running out.

Unfortunately, the cutoff is 10 years, Van Dyk said. They wont do this treatment on anybody whose injury is over 10 years old. Im at my deadline.

Positive attitude

After the accident, Van Dyk was told by doctors that it was very unlikely he would ever walk again and would need to be in a power wheelchair for the rest of his life.

Van Dyk said much to their surprise, he wasnt able to accept that and he worked as hard as possible to overcome the barriers the medical world presented him with, and within a few months started using a manual wheelchair every day.

Mobility however, did not return and life has been a constant struggle ever since.

Keeping Van Dyk moving forward has been a positive attitude, and he quickly adapted to his new life in a wheelchair. It was pretty easy to get over it. I never had trouble finding the positives in life. I kind of adapted. A lot of people would say that I am the most positive person that theyve ever met. I get compliments a lot on how well I actually dealt with the injury. It was difficult but it was easy at the same time.

Van Dyk is now turning to the public to help him regain some freedom.

I miss the active lifestyle I led prior to injury, and am getting really tired of sitting all day long with a limited amount of things I can do to entertain myself, Van Dyk said. Im as independent as a I can be and I still rely on a lot of help. If I can get anything back, even just a bit more upper body Im just looking for anything at this point.

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Scientists find mechanism behind precise spinal cord development – Medical Xpress

By raymumme

June 29, 2017 A normal developing spinal cord (left) showing precise patterns of gene activity (red, blue, green demarcating different types of cells). In a spinal cord in which one of the signals is disrupted (right) the accuracy of gene activity has been lost. Credit: Anna Kicheva

Scientists have uncovered how nerve cells in the spinal cord are organised in precise patterns during embryo development - a finding that could give insight into regenerative medicine.

As embryos grow and develop they need the right cell types to end up in the right places inside forming organs. This is particularly important in the spinal cord where different nerve cell types must be accurately positioned so that circuits can assemble properly to control muscle movement. But until now the mechanism underlying nerve cell organisation in the spinal cord has remained poorly understood.

In a study published in Science, researchers at the Francis Crick Institute, the Institute of Science and Technology (Austria) and Ecole Polytechnique Fdrale de Lausanne (Switzerland) report that cells destined to become nerve cells in developing mouse embryos use two different signals spreading from opposite sides of the spinal cord - the back and belly side - to measure their position accurately. Based on this map, they turn into the appropriate nerve cell type. The research was funded by the European Research Council and Wellcome.

The team of biologists, physicists and engineers found that the amounts of the two signals originating from the back and belly sides of the body affect gene activity in developing nerve cells. Based on this gene activity in early development, the cells turn into the appropriate nerve cell type for that position in the spinal cord.

"We've made an important step in understanding how the diverse cell types in the spinal cord of a developing embryo are organised in a precise spatial pattern. The quantitative measurements and new experimental techniques we used, as well as the combined effort of biologists, physicists and engineers were key. This allowed us to gain new insight into the exquisite accuracy of embryonic development and revealed that cells have remarkable ability of to orchestrate precise tissue development," says Anna Kicheva, Group Leader at IST Austria.

"We have shed light on the long-standing question of how developing tissues produce the right cells in the right place in the right numbers," says James Briscoe, Group Leader at the Francis Crick Institute. "It's likely that similar strategies are used in other developing tissues and our findings might be relevant to these cases. In the long run this will help inform the use of stem cells in approaches such as tissue engineering and regenerative medicine. However, there is still much more to learn and we need to continue developing these interdisciplinary collaborations to further our biological understanding."

The paper 'Decoding of position in the developing neural tube from antiparallel morphogen gradients' is published in Science.

Explore further: New study reveals how embryonic cells make spinal cord, muscle and bone

More information: "Decoding of position in the developing neural tube from antiparallel morphogen gradients" Science (2017). science.sciencemag.org/cgi/doi/10.1126/science.aam5887

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Growth Hormone and Rehabilitation Promoted Distal Innervation in a Child Affected by Caudal Regression Syndrome … – UroToday

By NEVAGiles23

We treated a 9-month old child affected by caudal regression syndrome (CRS) as we treat patients with spinal cord injuries. His spinal cord had been interrupted during fetal development at the L2-L3 level, therefore no innervation (sensitive or motor) existed beyond this level: flaccid paraplegia of inferior limbs and clubfoot, and neurogenic bladder and bowel. Moreover, there was sacral agenesis and right renal agenesis.

Treatment consisted in Growth Hormone (GH) administration plus two daily sessions of specific physiotherapy. GH treatment was given 5 days/week during 3-months followed by 15-days without GH administration; this protocol was repeated during 5 years, being GH doses periodically adjusted to the weight of the patient.

Changes observed in the child were assessed by carrying out the GMFM-88 test and evaluating sensitive and motor ASIA scores. GMFM-88 score at admission was 12.31%, while sensitive ASIA score was 168, and motor ASIA score was 50. Sensitive innervation began to appear quite earlier than motor innervation and reached the maximum ASIA score (224) two years after the treatment commenced. At this time a pelvic floor therapy was added (1 session/week) to rehabilitation. One year later the patient began to walk with crutches; then melatonin was given, at a daily dose of 50 mg (before going to bed) for counteracting the increased production of oxygen free radicals due to the physical effort induced by walking without the support of sacrum and the existence of hip luxation.

Five years after the treatment commenced the GMFM-88 test reached a score of 78.38% (maximum value: 100), while ASIA motor score was 84 (maximum value: 100). Full control of sphincters has been achieved.

To our knowledge this is the first case in which highly significant improvements have been obtained in this syndrome, until now considered to be irreversible. Most likely the early treatment with GH and rehabilitation was the factor responsable for the improvements observed. Since GH has been the only variable we introduced with regard to usual rehabilitation therapies, we think that the hormone induced the proliferation and differentiation of SC ependymal stem cells that led to the formation of a net of new specific nervous connections (perhaps arising from the last existing spinal nerve), although only a tractography may explain what was the origin of the new innervation, since the last MRI study performed when the child was 5-years old did not reveal any change in the vertebral columna and SC with regard to the first MRI study (7-days old). No adverse effects were observed during the treatent with GH and melatonin. Figure 1.3D reconstruction of a CT-SCAN. Age 4-years. It can be seen where the SC interrupted its development (hypoplastic L3), the existence of sacral agenesis, the articulation of iliac bones and the rotation of the left hip. Figure 2. 3-months after the treatment began. Note the abnormal position of the legs and feet. The child only could move his arms and trunk. Figure 3.1 year of treatment. Note the position of his feet. Sensitivity existed but he only could move by crawling with his arms and trunk.

Figure 4.After 2-years of treatment full sensitivity existed. In the image the child is signaling where he had been touched (his eyes were covered with a pillow.

Figure 5.4-years of treatment. The child is able to make plantar flexion (against resistence) and dorsiflexion (not showed) with both feet.

Figure 6.5-years of treatment. The child is able to get up from the floor and keep standing with arms outstretched.

Written By:Jess Devesa, MD, PhD,Scientific Direction, Medical Center Foltra, 15886 Teo, Spain

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Human head transplant: Chinese researchers claim success with rats – Alphr

By NEVAGiles23

A quick glance at your calendar will reveal that we're now in 2017. 2017, you may recall, is the year when contraversial surgeon Sergio Canavero has promised to perform the world's first human head transplant.

But just how feasible is a human head transplant? Is it the stuff of science fiction, or does it have a basis in current scientific thinking? Read on for everything you need to know about 2017 most alarming scientific development.

The most recent news comes from the journal CNS Neuroscience and Therapeutics, where Xiaping Ren from the Harbin Medical University claims to have successfully repaired severed spinal cords in rats using the same principals that Dr Canavero wants to use on humans before the year is out.

Nine rats were treated with polyethylene glycol (PEG). Eight were still alive a month after the operation, and by day 28 they had regained the ability to walk two were described as being "basically normal".

Canavero told Newsweek that this showed his critics were wrong: "Critics said the transected spinal cord is unrecoverable and thus a human head transplant is impossible...The scans show the reconstructed cord. No pain syndrome emerged over the duration of the study, again rebutting a critics worse than death remark."

Time will tell the team plans to move onto dogs next. It shoud be noted, however, that even if this is right and even if it is applicable to humans, this relates to repairing severed spinal cords not attaching a new head. If the research is accurate, it is indeed a point for Canavero and his proposed methods but we're a long way from it being anything close to the finished article.

A human head transplant is exactly what it sounds like taking one living head and putting it onto a new body.

But actually, thats a little misleading. In real terms, its a body transplant, as the head will be gaining a new body to control. However, as the term whole body transplant is already used to mean transferring the brain between bodies, calling it a head transplant makes it clear that the whole head is to be switched, brain included.

Until recently, a head transplant seemed totally implausible, but the Italian scientist Dr Sergio Canavero believes its possible, and intends to conduct the first surgery in 2017.

Canavero outlines the procedure in detail here, but these are the basics of the process. Remember: dont try this at home, kids.

The donor body and the head to be attached are first cooled down to 12-15C to ensure that the cells last longer than a few minutes without oxygen. The tissue around the neck is then cut, with the major blood vessels linked with tiny tubes. The spinal cord on each party is then severed cleanly with an extremely sharp blade.

"Post coma, Canavero believes the patient would immediately be able to move, feel their face and even speak with the same voice."

At this point, the head is ready to be moved, and the two ends of the spinal cord are fused using a chemical called polyethylene glycol, encouraging the cells to mesh. This chemical has been shown to prompt the growth of spinal cord nerves in animals, although Canavero suggests that introducing stem cells or olfactory ensheathing cells into the spinal cord could also be tried.

After the muscles and blood supply are successfully connected, the patient is kept in a coma for a month to limit movement of the newly fused neck, while electrodes stimulate the spinal cord to strengthen its new connections.

Following the coma, Canavero anticipates that the patient would immediately be able to move, feel their face and even speak with the same voice. He believes physiotherapy would allow the patient to walk within a year.

He explains his suggested methods in the TED talk below.

Sceptical would be a nice way of putting it. Horrified would, in most cases, be more accurate.

Dr Hunt Batjer has attracted headlines for being particularly blunt: I would not wish this on anyone. I would not allow anyone to do it to me as there are a lot of things worse than death.

Dr Jerry Silver witnessed the 1970s monkey head transplant experiment more on which later and describes the procedure as bad science, adding that just to do the experiments is unethical. This is a particular blow to Canavero, as he states that Silvers own work in reconnecting rats spinal cords should give hope to the human head transplant. Silver dismisses this: To sever a head and even contemplate the possibility of gluing axons back properly across the lesion to their neighbours is pure and utter fantasy in my opinion.

Dr Chad Gordon, professor of plastic and reconstructive surgery and neurological surgery at Johns Hopkins University, agrees that Canaveros claims are scientifically implausible. He told BuzzFeed: Theres no way hes going to hook up somebodys brain to someones spinal cord and have them be functional.

On the conservative side, were about 100 years away from being able to figure this out, he continued. If hes saying two, and hes promising a living, breathing, talking, moving human being? Hes lying.

Dr Paul Myers, associate professor of biology at the University of Minnesota at Morris, puts it even more explicitly: This procedure will not work... Try it with monkeys first. But he cant: the result would be, at best, a shambling horror, an animal driven mad with pain and terror, crippled and whimpering, and a poor advertisement for his experiment. And most likely what hed have is a collection of corpses that suffered briefly before expiring.

Others wonder whether Canavero might simply be enjoying the limelight with a PR stunt, including Dr Arthur Caplan, director of ethics at the NYU Langone Medical Centre. Describing the doctor as nuts, he explained to CNN: Their bodies would end up being overwhelmed with different pathways and chemistry than theyre used to, and theyd go crazy.

"We'll probably see a head on a robot before we see it on [another] body," he told Live Science.

Dr John Adler of Stanford University's school of medicine is slightly more optimistic... but not much more. "Conceptually, much of this could work, but the most favourable outcome will be little more than a Christopher Reeve level of function," he told Newsweek.

Canavero is aware of this criticism, claiming that silently hes received a lot of support from the medical community. Of Dr Batjers comments that the surgery would be a fate worse than death, Canavero is scathing. Hes a vascular surgeon. A vascular surgeon of the brain, yes, but he knows nothing, he argued. How can you say such a thing? Its incredible.

"The world is moving, the critics are dwindling. Of course, there will always be critics. Science teaches us that when you propose something groundbreaking, you must be confronted by criticism. If no critics really step forward, you are saying nothing special," he told Medical News Today.

Dr Canavero also believes that the operation could essentially be used to revive the dead, if brains were suitably frozen and stored. In an interview with German magazine Ooom, Canavero said: "We will try to bring the first of the company's patients back to life, not in 100 years. As soon as the first human head transplant has taken place, i.e. no later than 2018, we will be able to attempt to reawaken the first frozen head.We are currently planning the world's first brain transplant, and I consider it realistic that we will be ready in three years at the latest."

No-one has ever attempted a human head transplant before, and attempts on animals have to put it charitably had limited success.

Image: from Motherboard, uploaded under fair use from a 1959 issue of Life

The photo above really does show a dog with two heads and its not a fake. This was the work of Soviet scientist Vladimir Demikhov, and for four days the hybrid of two dogs lived as normally as such a scientific horror could be expected to. Then they died.

Demikhov tried the experiment more than 24 times, but was unable to find a way of avoiding the dogs dying shortly after surgery. Although the results are horrifying to see, Demikhovs research did pave the way for human organ transplants.

"For four days this hybrid of two dogs lived as normally as such a scientific horror could be expected to. Then they died."

But back to the topic of head transplants. The first time a straight swap was successful, was by Dr Robert White, in an experiment on a rhesus monkey in 1970. I feel the need to qualify the word successful with quotation marks, because although the monkey did live, he didnt live very long. Eight days, to be exact, and as the spinal cord wasnt attached to its new body, the monkey was paralysed for its remaining days. However, it could indeed see, hear, smell and taste before the body rejected the foreign head.

According to Canavero in his paper on human head transplants, the monkey lived eight days and was, by all measures, normal, having suffered no complications. However, Dr Jerry Silver who worked in the same lab as Dr White has more haunting memories. He toldCBS: I remember that the head would wake up, the facial expressions looked like terrible pain and confusion and anxiety in the animal. The head will stay alive, but not very long. It was just awful. I dont think it should ever be done again.

More recently, Chinese doctor Xiaoping Ren claims to have conducted head transplants on more than 1,000 mice. The Wall Street Journal reports to have witnessed a mouse with a new head moving, breathing, looking around and drinking. But, crucially, none of these mice have lived longer than a few minutes.

Still, Dr Rens studies continue, and the latest reports are said to be promising, offering a possible answer to the risk of severe blood loss (or brain ischemia) during transplantation. The experimental method that we have described can allow for long-term survival, and thus assessment of transplant rejection and central nervous system recovery, bringing us one step closer to AHBR in man, the researchers wrote.

Ren himself has not ruled out taking part in the first human head transplant operation, according to the Daily Mail. "A human head transplant will be a new frontier in science. Some people say it is the last frontier in medicine. It is a very sensitive and very controversial subject but if we can translate it to clinical practice, we can save a lot of lives," he said.

"Many people say a head transplant is not ethical. But what is the essence of a person? A person is the brain not the body. The body is just an organ," he added.

In January 2016, Canavero told New Scientist that a head transplant had been successfully completed on a monkey in China, although details were sparse. "The monkey fully survived the procedure without any neurological injury of whatever kind," he said, although the article notes that the monkey only kept alive for 20 hours after the surgery for "ethical reasons," limiting its use as a comparison somewhat.

In September 2016, Canavero revealeda further trial of the head transplant on dogs.New Scientisthas seen video footage of a dog appearing to walk three weeks after its spinal cord was severed, with Canavero claiming that the outcome is the result of the same techniques he plans to use on Spiridonov next year.

However, speaking to a number of scientists for their view on the new evidence, New Scientistcould find few sceptics converted. "These papers do not support moving forward in humans," said Jerry Silver a neuroscientist at Cape Western Reserve University in Ohio.

"The dog is a case report, and you cant learn very much from a single animal without controls. They claim they cut the cervical cord 90 per cent but theres no evidence of that in the paper, just some crude pictures," added Silver.

In May 2017, Canavero claimed success with another animal model: rats. Canavero and his team of Chinese surgeons claimed they were able to transplant the head of a donor rat onto the back of a larger one, creating a two-headed animal. The creature's donor head was allegedly able to blink and respond after the operation, although it only lived for 36 hours, which may not inspire confidence even with rodents' reduced lifespans.

You could say so, though Canavero doesn't see it quite like that. In fact, controversially he sees it more as a failure of other types of medicine, telling Medical News Today, "It will be about curing incurable neurological disorders for which other treatments have failed big time, so gene therapy,stem cells- they all just came to nothing. We have failed despite billions of dollars being poured into this sort of research."

"So actually, head transplant or body transplant, whatever your angle is, is actually a failure of medicine. It is not a brilliant success, a brilliant advancement to medical science. When you just haven't tackled biology, you don't know how to treat genes, you don't really understand, and you really need to resort to a body transplant, it means that you've failed. So this must not be construed as a success of medical research," he added.

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He broke ground in stem-cell research. Now he’s running for Congress. – Washington Post

By daniellenierenberg

The small pack of scientists running for political office has grown by one.

Stem-cell researcher Hans Keirstead, 50, announced last week that he will try to unseat Californias Rep. Dana Rohrabacher (R). Keirstead, a Democrat with a PhD in neuroscience from the University of British Columbia, was a professor at the University of California at Irvinebefore launching and selling several biotech companies.

Rohrabacher, who represents the 48th District in Southern California, has been in Congress since 1988. Democrats there see 2018 asa vulnerable year for the incumbent. Although Republicans outnumber Democrats in thedistrict, Hillary Clinton swung it in the 2016 election. And Rohrabacher has come under scrutiny for his support of acloser relationship with Russia. In May, the chair of Orange County Democrats toldThe Washington Post that challengers were coming out the woodwork to oppose him. Five candidatesbesides Keirstead have declared they are running for the seat.

Keirstead emerged from academic and entrepreneurial fields. Hepioneered a technique to purify stem cells You cant go putting toenails into the spinal cord, he said and applied this method to spinal-cord injuries and diseases such ascancer and amyotrophic lateral sclerosis, or ALS. In 2014,he sold a stem-cell company in a deal reportedly worth more than $100 million. (He will not fundhis own campaign, he told the Los Angeles Times.) Keirstead has thesupportof314 Action, a nonprofit group that encourages scientists to seek public office.

The Post spoke by phone with the first-time candidate. The following is lightly edited for space and clarity.

TWP: Your opponent, who is a member of the House Science Committee, told Science magazine in 2012 that he loved science. How would you compare your approaches to science?

Keirstead:Im delighted that Dana Rohrabacher loves science. Thats fabulous. But Im also very convinced that he doesnt understand science. Theres a real big difference. If you love science, thats one thing. If you dont understand it, you cant effect change, and you make wrong decisions.

Dana Rohrabacher does not understand global warming. He actually attributed it to the flatulence of dinosaurs, in a serious manner, a while back. [Rohrabacher hassaid this wasa joketo make fun of scientists who study cow methane.]

His inaction and lack of understanding has tremendous detriment on the scientific community. Likewise is the funding to health care and how to fix the health-care system that [former president Barack] Obama put in place. That was not a perfect system by any means; its got problems.But it has also bettered our system. It needs to be worked with in order to further better our system.

TWP: Has your career in stem-cell research influenced your politics?

Keirstead:I was front and center in the national and international debate on stem cells. I was the first scientist in the world to have developed a treatment for spinal-cord injury using stem cells. The dramatic nature of the recovery we saw in rodents, going from paralyzed to walking, drew a great deal of attention and really put me at the center of this issue as it was just coming to light in the public forums.

I did a lot of advising of senators and congressmen all throughout those years and periodically since that time. . . . I was one of the key scientific advisers to Proposition 71 that turned into the $3 billion California Institute of Regenerative Medicine, a not-for-profit that distributes $300 million every year for regenerative medicine in a broad sense.

That was a very good example of how medical breakthroughs and discoveries and advancement are not at odds with economic development. You do not have to cut medical budgets to stimulate the economy. Any scientist and medical doctor will tell you: Give me some time, and I will generate a treatment. And most of the time they are right. What happens with that treatment is small companies are born, people stop dying, quality of life improves.

I see what the governments doing right now as very much opposite that. Frankly, when I look at the deficits of Congress, I see why. When I look at who is in the administration, the types of individuals that we have in Congress, I see very hard-working people doing what they feel is a terrific job. But there is just not the broad and deep field experience in the medical and health-care sectors.

TWP: Was it this perceived deficit that motivated you to run for Congress?

Keirstead:First and foremost, I see it as a continuation of my lifelong pursuits of trying to help people.

I see Congress as a larger stage to effect positive change. If I could have some positive influence in Congress, I could aid [those] that are trying to do good in the world but are having difficulty.

Let me give you an example: Im now expanding into brain cancer. Im running a Phase 2clinical trial with my team.I will not be able to do that if these policy changes of Trumps are instituted and a small company like mine is faced with double user fees. Its not in the budget. I cant ask an investor for another half of a million dollars for an administrative fee.

I see the administration putting insurmountable challenges in front of small businesses. Im about generating treatments to help people, putting medicines in peoples homes. And Im looking to the future and seeing that tap shut off.

Read more:

As scientists erupt in protest, a volcanologist runs for Congress

This group wants to fight anti-science rhetoric by getting scientists to run for office

Tens of thousands marched for science. Now what?

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Spinal cord | Define Spinal cord at Dictionary.com

By LizaAVILA

Contemporary Examples

Infections can strike joints, airways, the lungs, the brain and the tissues lining the spinal cord, or the bloodstream.

Other spinal cord regeneration efforts involve using stem cells to regrow damaged or lost neurons.

As a result, Smith lost his right arm underneath the elbow and parts of his leg, hip and spinal cord.

Generally, a human will only be infected if they eat the nerve tissuebrains or spinal cordof an infected animal.

The bulleta live fire bulletexited through his back but not before severing his spinal cord.

British Dictionary definitions for spinal cord Expand

the thick cord of nerve tissue within the spinal canal, which in man gives rise to 31 pairs of spinal nerves, and together with the brain forms the central nervous system

spinal cord in Medicine Expand

spinal cord n. The thick, whitish cord of nerve tissue that extends from the medulla oblongata down through the spinal column and from which the spinal nerves branch off to various parts of the body. Also called spinal marrow.

spinal cord in Science Expand

The long, cordlike part of the central nervous system that is enclosed within the vertebral column (spine) and descends from the base of the brain, with which it is continuous. The spinal cord branches to form the nerves that convey motor and sensory impulses to and from the tissues of the body.

spinal cord in Culture Expand

The thick column of nerve tissue that extends from the base of the brain about two thirds of the way down the backbone. As part of the central nervous system, the spinal cord carries impulses back and forth between the brain and other parts of the body through a network of nerves that extend out from it like branches.

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Familial ALS Linked to Both Neuron and Astrocyte Pathology – Alzforum

By LizaAVILA

17 Jun 2017

Animal models and engineered cells have contributed their fair share of insight into the pathogenesis of amyotrophic lateral sclerosis (ALS), but researchers do not often have the opportunity to peer into afflicted human neurons. In a study published May 30 in Cell Reports, researchers led by Rickie Patani and Sonia Gandhi at University College London offer a new model for human disease by using motoneurons and astrocytes derived from amyotrophic lateral sclerosis (ALS) patient stemcells.

The researchers generated spinal motoneurons and astrocytes from induced pluripotent stem cells (iPSCs) of ALS patients carrying mutations in the valosin-containing protein (VCP) gene. VCP mutations account for 2 percent of familial ALS cases and have been linked to other disorders as well, including hereditary inclusion body myopathy with Paget disease of bone and frontotemporal dementia (IBMPFD), jointly termed multisystemproteinopathy.

Previously, researchers reported that VCP mutations promoted the formation of cytoplasmic aggregates of TDP-43,one of the hallmarks of motoneuron disease, and that these aggregates were at least partially responsible for the VCP-induced neurodegeneration seen in a fly model (Neumann et al., 2007; Ritson et al., 2010).

Few studies have tested what VCP mutations do to human neurons, however. Using an iPSC-derived neuronal model, Virginia Kimonis at the University of California, Irvine, found that the VCP R155H mutation boosted cells levels of TDP-43 and several proteins involved in protein disposal (Dec et al., 2014).

In search of a more complete view of how VCPs effects unfold over time, first co-authors Claire Hall, Zhi Yao, Minee Choi, and Giulia Tyzach used iPSC-derived populations of spinal cord motoneurons and astrocytes to track several cellular functions. The cells originated from two patients (four clones) with VCP mutations and three healthycontrols.

TDP-43 (red) stays in the nucleus (blue) in control motoneurons (left) but leaks into the cytoplasm in three-day old VCP-mutant motoneurons (right). [Cell Reports, Hall et al.,2017.]

More VCP-mutant motoneurons than controls died; they also made fewer synapses with their neighbors, and had less intense and fewer coordinated bursts of firing than controls. Monitoring the whereabouts of TDP-43, the authors found no difference between mutant and normal cells when the cells were at an early stage of differentiation, as neural precursor cells. But by the third day after becoming motoneuron-like, the mutant cells were leaking TDP-43 from their nuclei into the cytoplasm (see image above). At the same time, they had increased levels of markers of endoplasmic reticulum (ER) stress, became less able than controls to survive an ER stress assay, and began producing reactive oxygen species (ROS) at a higherrate.

By day 17, the mutant motoneurons had sickly ER tubules. Some were swollen, others cozied up to mitochondria, both signs of continued ER stress. The neurons also had low mitochondrial membrane potential and low glutathione levels, indicating mitochondrial dysfunction and oxidative stress,respectively.

Putting these findings together, Patani and Gandhi suggested that cyotosolic TDP-43 generates ER stress, which next triggers increased tethering of the ER to mitochondria. This could depolarize mitochondria, which could impair mitochondrial function and ultimately lead to high levels of free radical production and oxidative stress.The findings support a role for TDP-43 wreaking havoc in the cytoplasm, saidPatani.

The mechanism that links TDP-43 and ER stress remains uncertain, said Kimonis. Patani and Gandhi acknowledge the link is probably complex, noting that, in addition to cyotplasmic TDP-43 aggregates inducing ER stress, ER stress itself seems to drive TDP-43 leakage (Walker et al., 2013).

The researchers then probed how mutant VCP might affect astrocytes. Studies of astrocytes in other ALS models have yielded varying results depending on the mutation. Superoxide dismutase 1 (SOD1) mutations, for example, can turn astrocytes into motoneuron killers (see Oct 2011 news),but it is unclear if they endanger the survival of the astrocytes themselves. Conversely, mutations in TDP-43 seem to sicken astrocytes without making them toxic to neighboring neurons (Serio et al., 2013).

On the left, healthy astrocytes (red) protect VCP-mutant motoneurons (yellow) from death (green). VCP-mutant astrocytes are much less protective (right). [Courtesy of ZhiYao.]

Interestingly, Patani and Gandhi found that VCP mutations had both cell-autonomous and non-cell-autonomous effects. They increased astrocytes risk of death and rendered them less able to support the survival of both control and VCP-mutant motoneurons (see image at right). The authors also found that the cell-autonomous effects on astrocytes differed from those in motoneurons. VCP-mutant astrocytes seemed more resistant when challenged with an ER stressor and had only a transient drop in mitochondrial membrane potential and a transient increase in ROS, with no change in glutathionelevels.

The study is a validation of key prior findings using iPS-derived neurons and glia from patients, which is a nice advance, wrote Paul Taylor at St. Jude Childrens Research Hospital in Memphis, Tennessee. The characterization of the role of glia is also interesting and potentially important.

Looking ahead, Patani and Gandhi want to generate isogenic controls, that is, cells derived from the same patients but with repaired VCP mutations. They also want to create iPSC-derived upper motoneurons, and to better understand muscle pathology, Kimonis hopes to extend her investigation of iPSC-derived muscle cells (Llewellyn et al., 2017).

Other model systems will be of value, too. iPSC-derived models are not equivalent to the decades-old cells inhabiting an adult nervous system. A study of dopaminergic neurons, for example, revealed that gene expression and DNA methylation patterns differed between iPSC-derived neurons and their in vivo counterparts (Roessler et al., 2014).

In the long term, Patani hopes that shedding light on the sequence of events that marks motoneuron degeneration in human cells will enable researchers to more effectively search for ALS therapies.MarinaChicurel

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Eva Feldman steps down as Taubman Institute director – The Detroit News

By JoanneRUSSELL25

Eva Feldman, M.D., Ph.D.(Photo: Detroit News file photo)

World-renowned researcher Dr. Eva Feldman is stepping down as director of the University of Michigans A. Alfred Taubman Medical Research Institute, an organization that supports research for cures for debilitating and deadly diseases.

Feldman was the founding director of the institute launched by philanthropist and businessman A. Alfred Taubman, who died in 2015 at age 91. Feldman spent the last 10 years at the helm as the institute developed new drugs, surgeries and therapies for diseases such as adult and childhood cancer, diabetes, cardiovascular disease and, Feldmans research interest, amyotrophic lateral sclerosis.

When Alfred and I began the institute 10 years ago together, we had a vision of creating an institute where clinician scientists would take their most novel discoveries from their laboratory and translate that into patient clinical trials, said Feldman, adding that the team of four has grown to over 200. Weve really been able to realize that vision.

Feldman, 65, said Thursday that she raised the institute from its infancy.

Its now time for the next person to take it through its adolescence, because its still growing, she said. So it just seemed the perfect time to pass the baton to someone to have the next 10 best years of their life the way I just had the 10 best years of my life.

The institute will select the next director soon, Feldman said.

A Russell N. DeJong Professor of Neurology, Feldman will continue to run the ALS clinic at UM and her own laboratory, Program for Neurology Research & Discovery. Her team of 30 scientists have spent years working on human clinical trials that may lead to a treatment for ALS, a neurological disease also known as Lou Gehrigs disease. Most ALS patients lose the ability to walk and talk, and death may occur within three to five years of diagnosis.

In 2010, Feldman started the first human clinical trial approved by the U.S. Food and Drug Administration to use stem cells to treat ALS. The FDA recently approved Feldman to move onto the final, nationwide phase of the trial that involves injecting stem cells into the spinal cord of ALS patients. If approved, the drug could be marketed to patients.

Besides focusing on the trial, Feldman said shell have more time to do a deep dive into why people with diabetes get neurological complications.

She also was elected to the National Academy of Medicine and plans to use her position to help others understand the value of philanthropy.

Philanthropy can be a game changer Al Taubman showed us that and one of my goals is to help other clinician scientists throughout the country understand the process, she said.

Feldman said shes much closer to a cure for ALS, but were not there yet. For now, she wants to press the pause button on the disease.

When the patient comes to me, I want to be able to offer them a therapy so they will stay right where they are the first day I see them, she said. I dont think that stem cells will necessarily make people go back to where they are before they got ill, but if we can stop the disease in its tracks, my patients will be happy and I will be happy.

Feldman was named a 2011 Detroit News Michiganian of the Year. Shes served as the president of the American Neurological Association, the third woman to hold the position in 130 years, and was named one of Americas Top Doctors in 2016.

ssteinberg@detroitnews.com

(313) 222-2156

Twitter: @Steph_Steinberg

Read or Share this story: http://detne.ws/2tsQJnb

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